MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TIBIAL RESECTION BLOCK 10 DEG; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number	249258000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Instrument broken.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the device confirmed the failure mode as reported.The devices were reviewed by bioengineering and a report was received stating; it was unlikely that a manufacturing defect was present depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.A complaints search identified similar complaints received.The devices were reviewed by bioengineering; one section of a steinmann pin lodged inside the start hole of a tibial osteotomy block.The complaint reported two issues, the first was an issue with the compatibility of depuy steinman pins (869117) with a pin adapter instrument from a different manufacturer (tanana medical instruments).Given that depuy steinman pins are not intended to be used with this instrument, the design cannot be said to be defective in relation to this issue.The complaint then reported an event whereby a depuy steinman pin had broken and was stuck inside a tibial osteotomy block (249258000).Visual inspection of the returned parts confirmed this.Upon visual inspection, the pin appeared straight and sharp and had a diameter of 3.1mm (within spec).A very small buildup of material was noted where the pin was inserted into the block.Helical scratching was visible on the shaft of the pin, with a variable pitch.As part of the investigation, the pin was removed from the block which revealed deep scratches on the section that had previously been inside the cutting block.Some scratching was also visible on the inside bore of the cutting block, but an undamaged pin was still able to slide through.It is likely that this damage was made worse through the forced removal of the pin from the block during this investigation.It appeared as though some amount of abrasive wear had caused a buildup of metal debris between the pin and block to the point where the pin had become jammed.The forces subsequently applied in this condition were then enough to fracture the pin.The manufacture date of the cutting block is unknown, however the surface has marks and scratches consistent with repeated use and reprocessing cycles ¿ presumably without the issues reported in this complaint.There is not enough information provided to determine the exact root cause of this complaint, however it is likely that off-label use was a contributing factor.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint (b)(4).Investigation summary : examination of the device confirmed the failure mode as reported.The devices were reviewed by bioengineering and a report was received stating; it was unlikely that a manufacturing defect was present depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TIBIAL RESECTION BLOCK 10 DEG
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8301083
• Report Number: 1818910-2019-83089
• Device Sequence Number: 985878
• Product Code: JWH
• UDI-Device Identifier: 10603295126010
• UDI-Public: 10603295126010
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 249258000
• Device Lot Number: AH1197F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 02/11/2019; 04/15/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 02/20/2019; 04/15/2019
• Patient Sequence Number: 1