MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS TIB RESC BLK 7 DEG; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number 228705000

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that the steinmann pin (p/n: 869117p) was caught in the steinmann pin adapter (manufactured by tanana medical instruments) when the surgeon struck the steinmann pin by using the tibial osteotomy block (p/n: 228705000) during tka surgery.It was further reported that the steinmann pin was broken.It was confirmed the triangular part of the steinmann pin was broken and it was remained in the steinmann pin adapter.The surgery was completed, and it was unknown whether there was a surgical delay or not.There were no broken fragments in the patient right knee joint and there was no adverse consequence to the patient.No further information is available.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 returned devices confirms the complaint, the steinmann pin is stuck in the tibial resection block, and the proximal end of the pin (attachment feature) has fractured.Root cause undetermined.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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # :(b)(4).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.Investigation summary
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> examination of the returned devices confirms the complaint, the steinmann pin is stuck in the tibial resection block, and the proximal end of the pin (attachment feature) has fractured.Root cause undetermined.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.Investigation methods: was patient affected: no.Device history reviewed: no.Lot trace obtained: no.Complaints database searched: yes.Product checked: yes.Label checked: no.Product pulled from stock for inspection: no a review of complaint databases did not identify any anomalies.The device was reviewed by bioengineering and a report was received stating; examination of the returned devices confirms the complaint, the steinmann pin is stuck in the tibial resection block, and the proximal end of the pin (attachment feature) has fractured.The fractured piece was not returned for examination, the complaint description indicates this portion is stuck in the pin adaptor.Note that the pin adaptor used was not a depuy device, therefore this is considered off label use.The resection block shows signs of significant use, with list of dents and scratches on all surfaces, with the highest concentration of damage on the resection surface.The pin was disassembled from the cutting block by r&d, and found severe deformation of the pin at the point where it exited the cutting block.A burr was identified within the bore where the pin was stuck after disassembly.The origin of the burr is unknown; however it is very unlikely that the burr occurred during manufacture due to the age of the device.A complaint for the same failure mode on similar devices was logged from the same hospital recently (b)(4).With this information and the documented off label use, some level of use error may be contributing to the event, however this cannot be confirmed.It was unlikely that a manufacturing defect was present.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.

• Brand Name: LCS TIB RESC BLK 7 DEG
• Type of Device: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8432058
• MDR Text Key: 139428192
• Report Number: 1818910-2019-87725
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 228705000
• Device Lot Number: AA0194B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1