MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP*2 DISTAL FEM CUTTING BLOCK; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number	96-6115
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Usfda mdr determination: there is no indication that the time delay occurred at a critical procedure step where high risks to the patient might be present.There is no indication that the delay resulted in any impact to the expected surgical outcome.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
It was reported that the drill bit that surgeon was using, from the depuy drill bit and steinman pin packet (ref.86-4192, lot j68550w), binded up in the right lateral hole of the distal femoral cutting block he was using.The drill was being used to drill the holes in the patient's distal femur, for the steinman pins that are used to pin the cutting block to the femur.Surgeon then used a pin puller to remove the stuck (wedged) drill bit from the cutting block.A second drill bit was used to drill the hole.It was inserted in reverse rotation, so it too would not bind up in the right lateral hole of the cutting.Surgeon believes that there may be something wrong with the hole in the cutting block, since he said the same thing happened to him two weeks prior.The sales rep assured the surgeon that he would report the incident and request that a replacement cutting block be order for the depuy synthes loaner instrumentation set.A replacement block is needed before he uses the same set of instruments at the same location on (b)(6) 2020.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device on (b)(4) could not confirm the reported event.However, additional wear and damage to the overall device was found consistent with normal use and servicing.The investigation did not establish a need for a broader investigation or corrective action at this time.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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.H10 additional narrative: added d10.Corrected: h3.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 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 device on (b)(4) could not confirm the reported event.However, additional wear and damage to the overall device was found consistent with normal use and servicing.The investigation did not establish a need for a broader investigation or corrective action at this time.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.

• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9721618
• Report Number: 1818910-2020-05146
• Device Sequence Number: 329584
• Product Code: HAW
• UDI-Device Identifier: 10603295246862
• UDI-Public: 10603295246862
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K043223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/31/2020

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 Model Number: 96-6115
• Device Catalogue Number: 966115
• Device Lot Number: J0901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 02/11/2020; 03/16/2020; 03/16/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 03/10/2020; 03/16/2020; 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR