MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-09-14 for ROD TO ROD COUPLING HOFFMANN II COMPACT 5/5MM 49401010 manufactured by Stryker Gmbh.
[54675273]
Once the investigation has been completed any additional information will be reported in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[54675274]
On (b)(6) 2016, the patient had surgery with a hoffmann2 compact. On (b)(6) 2016, the surgeon has tightened up more the rod coupling, the rod coupling broke.
Patient Sequence No: 1, Text Type: D, B5
[63644300]
The reported incident that the rod to rod coupling hoffmann ii compact 5/5mm broke could be confirmed, since the returned device matched the reported event. Based on the investigation, the root cause was determined to be user related. The failure was caused by overtorqueing of the screw of the coupling. The device inspection revealed breakage of the screw is consistent with overtorqueing. Since this screw is the one that holds all of the pieces of the coupling together, it is natural that once it breaks, all of the components will fell off. It was reported that the instrument felt loosen and this is why the surgeon attempted to tighten again the screw, however upon this attempt, the strength used was so high that it caused the breakage of the screw. The looseness could not be confirmed since, not only the coupling was already broken, but also because not all of the coupling components were returned for investigation. Care should be taken not to overtighten the screw of the coupling as this may cause damages to the instrument, just like the present event. A review of the device history for the reported lot did not indicate any abnormalities. No corrective actions are required at this time. A review of the labeling did not indicate any abnormalities. No indications of material, manufacturing or design related problems were found during the investigation. If any further information is provided, the investigation report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[63644301]
On (b)(6) 2016, the patient had surgery with a hoffmann2 compact. On (b)(6) 2016, the surgeon has tightened up more the rod coupling, the rod coupling broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2016-00448 |
| MDR Report Key | 5949401 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-09-14 |
| Date of Report | 2016-12-29 |
| Date of Event | 2016-08-16 |
| Date Mfgr Received | 2016-12-01 |
| Device Manufacturer Date | 2015-05-14 |
| Date Added to Maude | 2016-09-14 |
| 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 | MR. ANNA JUSINSKI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER GMBH |
| Manufacturer Street | BOHNACKERWEG 1 POSTFACH |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROD TO ROD COUPLING HOFFMANN II COMPACT 5/5MM |
| Generic Name | SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER |
| Product Code | JEC |
| Date Received | 2016-09-14 |
| Returned To Mfg | 2016-11-29 |
| Catalog Number | 49401010 |
| Lot Number | J12745 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER GMBH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-09-14 |