MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-11-09 for MAYFIELD SWIVEL HORSESHOE HEADREST A1012 manufactured by Integra Lifesciences Corporation Oh/usa.
[59561341]
Integra has completed their internal investigation on 31 oct 2016. The investigation included: methods: evaluation of actual device. Review of device history records. Review of complaint history. Results: evaluation of device: engineering and quality were able to confirm the customer complaint. The thread inside the starburst of the horseshoe casting is stripped, a? 0. 357? - (minus) gage pin can pass for 0. 235? Inside the threads while this is larger than the minor and pitch diameters of a 3/8-16 2b-unc thread form. The remaining threads cannot pass a 3/8-16 2b unc go thread gage all the way through (0. 1865? Short). The bolt stack-up required 0. 5625? Of thread engagement (from a 0. 125? Chamfer on the end) and horseshoe casting (b)(4) only allows a thread 0. 5585? , when engaging allowing 0. 004? Of play. Device history record reviewed for this product id under lot codes 078088, 078089 and 078832 manufactured between october-december of 2008 were produced during this time at quantities of (b)(4) respectively, show no abnormalities related to reported incident found. This device passed all required inspection points with no associated mrr? S, variances or rework. No previous service history is on file. A two year lookback in (b)(6) for this reported failure and or related to " headrest failed to attach due to stripped threads" for this product id shows that 2 complaints were received including this case, see below. No new design or manufacturing trends have been identified. This issue will be monitored. In summary: the unit was built in 2008, and has signs of definite use. The failure of the threads is most likely attributed to wear and tear and possible misuse. The misuse consideration is due to the generation the force required to remove the amount of material from the threads past the pitch diameter.
Patient Sequence No: 1, Text Type: N, H10
[59561342]
A customer tried to use the a2009 ultra 360 system with the a1012 mayfield swivel horseshoe headrest but it failed to attach. There was a gap between them and could not be locked tightly. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004608878-2016-00303 |
| MDR Report Key | 6090893 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-11-09 |
| Date of Report | 2016-09-08 |
| Date Mfgr Received | 2016-10-31 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2016-11-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER BINA PATEL |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Street | 4900 CHARLEMAR DRIVE |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAYFIELD SWIVEL HORSESHOE HEADREST |
| Generic Name | SKULL CLAMPS AND HEADREST SYSTEMS |
| Product Code | HBM |
| Date Received | 2016-11-09 |
| Returned To Mfg | 2016-09-08 |
| Catalog Number | A1012 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Address | 4900 CHARLEMAR DRIVE 4900 CHARLEMAR DRIVE CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-09 |