MAUDE Adverse Event Report: DEPUY IRELAND 9616671 SIG HP REV 4IN1 CUT BLK SZ4; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number	201103003
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.
Event or Problem Description
It was reported that the surgeon was driving the pin into the tc3 size 4 cutting block and through the augment when the pin bent and got bound up breaking the pin head off into the pin driver and bending the pin at the same time.
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.  corrected: (method, conclusion, and result).Product complaint # (b)(4).Investigation summary : the complaint sample consisted of (1) 950502071 hp power pin driver, (1) 950502089 hp threaded pin headed, (1) 201103023 sig hp rev distal spacer 12mm and (1) 201103003 sig hp rev 4in1 cut blk sz4 the sample was submitted with the hp threaded pin headed jammed in the pin hole of the sig hp rev 4in1 cut blk sz4.The pin head has broken off and is lodged inside the hp power pin driver and cannot be removed.In addition, the pin is significantly bent and deformed.The sig hp rev distal spacer 12mm was returned stuck on the bent hp threaded pin headed.The spacer cannot be removed due to the bent condition of the pin.The stuck spacer is secondary to the pin damage.Although the investigation could not conclusively identify the root cause of the pin breakage/damage, it is likely off-axis loading of the pin into the block pin hole was a contributing factor.The hp power pin driver continued to rotate on the head of the pin after the pin became jammed in the block resulting in torsional fracture and bending of the pin.The root cause is being attributed to unintended user technique of off-axis loading of the pin into the block pin hole.The damage to the pin driver and spacer were secondary to the pin breakage/damage.Based on the investigation determination of unintended user error as the primary root cause, the need for corrective action is not indicated.Complaint trends will be monitored by post market surveillance through sep-419.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIG HP REV 4IN1 CUT BLK SZ4
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8412684
• Report Number: 1818910-2019-87035
• Device Sequence Number: 303312
• Product Code: HTZ
• UDI-Device Identifier: 10603295081241
• UDI-Public: 10603295081241
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2019

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: 201103003
• Device Lot Number: SO2008647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019; 04/05/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/05/2019; 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1