MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-03-19 for IN-CONDL CHISEL 8X10X7 3/4 IN 242101000 manufactured by Depuy Orthopaedics Inc Us.
[139201508]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device is an instrument and is not implanted/explanted. Investigation summary: examination of the returned device confirmed the reported event. Additionally, the tip of the device was identified as chipped. The complaint consisted of (1) 242101000 in-condl chisel 8x10x7 3/4 in, lot number s02015050 examination of the submitted in-condl chisel 8x10x7 3/4 in confirmed the device was worn. Additionally, the tip of the device was identified as chipped. The broken off fragment was not returned. The initial reporting stated no pieces of the device were left in the patient. The radel handle has scratches and discoloration expected with normal use of the instruments. Wear marks were also present. A complaint database search against product code 242101000 found similar reported events. Additional reported event was investigated and found the tips of the chisels were loaded beyond the material limit resulting in mixed mode ductile and brittle overload of the material and fracture. The root cause is attributed to user error/technique. The tip of the chisel was loaded beyond the material limit resulting in mixed mode ductile and brittle overload of the material and fracture. No evidence was found indicating product error was a contributing factor to the device breakage and the need for corrective action was not indicated. Monitor complaints. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
[139201509]
It was reported that the tips of the instruments were worn and need replacing. There were no broken parts, no broken pieces and no instruments left in the patient. Examination of the returned device confirmed the reported event. Additionally, the tip of the device was identified as chipped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-87742 |
| MDR Report Key | 8432349 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-03-19 |
| Date of Report | 2019-02-28 |
| Date of Event | 2019-02-04 |
| Date Mfgr Received | 2019-03-26 |
| Date Added to Maude | 2019-03-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 193800988 |
| Manufacturer Country | US |
| Manufacturer Postal | 193800988 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IN-CONDL CHISEL 8X10X7 3/4 IN |
| Generic Name | KNEE INSTRUMENT : CUTTING INSTRUMENTS |
| Product Code | FZO |
| Date Received | 2019-03-19 |
| Returned To Mfg | 2019-02-19 |
| Catalog Number | 242101000 |
| Lot Number | S02015050 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-19 |