MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BONE HOOK-SHAPE ARM 206MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	398.756
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	09/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.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 on (b)(6) 2020, the surgeon was attempting to use a synthes collinear clamp on a proximal femur fracture and the clamp would not tighten properly.The clamp tightened while the surgeon was squeezing the trigger/handle but it would loosen once the trigger was released rather than remain tight.The collinear clamp was removed and a loman was applied.There was a surgical delay of fifteen minutes because, it took the surgeon approximately fifteen minutes to remove the collinear clamp, extend his incision, and apply a loman clamp.The fracture was able to be reduced.The procedure was successfully complete.This is report 1 of 2 for (b)(4).
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.Device history lot part: 398.756, lot: 09-5791, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 01.March 2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: investigation summary: background: 10/26/2020: updated event description: it was reported that on (b)(6) 2020, during proximal femoral nailing system (tfna) for proximal femur fracture, the surgeon was attempting to use a synthes collinear clamp on a proximal femur fracture and the clamp would not tighten properly.The clamp tightened while the surgeon was squeezing the trigger/handle but it would loosen once the trigger was released rather than remain tight.The collinear clamp was removed and a loman was applied.There was a surgical delay of approximately fifteen (15) minutes to remove the collinear clamp.The surgeon extended his incision and apply a loman clamp which did reduce the fracture.The procedure was successfully complete.There was no patient consequence.This complaint involves two (2) devices.Investigation flow: device interaction/functional.Visual inspection: the bone hook-shape arm 206mm (product code: 398.756 & lot no: 09-5791) was received at us cq.The visual inspection of the received device indicated several nicks on device surface and hook tip edges.No other damages were observe don the device.Functional test: the functional test cannot be performed as the device was received itself at us cq.The mating device (sliding mechanism) was sent to service & repair team and it was found that the mating device was missing screens, lube, oil and clean.Therefore the alleged device interaction issue cannot be confirmed for the complaint device as there were no damages observed on the device that would contribute to the complaint condition.Moreover, it appears that the alleged complaint condition occurred due to the missing components in the mating device.Can the complaint be replicated with the returned device(s)? unable to perform.Dimensional inspection: the dimensional inspection was not performed as no damages were observed on the device that would contribute to the complaint condition.Document/specification review: complaint was not confirmed, the alleged complaint condition may occurred due to the damaged mating device.Investigation conclusion: the complaint condition was not confirmed as no damages were observed on the device that would contribute to the alleged complaint condition.Several nicks were observed on the device which would not cause the alleged device interaction issue.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device was used for treatment, not diagnosis.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
10/26/2020: updated event description: it was reported that on (b)(6) 2020, during proximal femoral nailing system (tfna) for proximal femur fracture, the surgeon was attempting to use a synthes collinear clamp on a proximal femur fracture and the clamp would not tighten properly.The clamp tightened while the surgeon was squeezing the trigger/handle but it would loosen once the trigger was released rather than remain tight.The collinear clamp was removed and a loman was applied.There was a surgical delay of approximately fifteen (15) minutes to remove the collinear clamp.The surgeon extended his incision and apply a loman clamp which did reduce the fracture.The procedure was successfully complete.There was no patient consequence.This complaint involves two (2) devices.

• Brand Name: BONE HOOK-SHAPE ARM 206MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10726292
• Report Number: 2939274-2020-04795
• Device Sequence Number: 19864477
• Product Code: LXH
• UDI-Device Identifier: 10886982201591
• UDI-Public: (01)10886982201591
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 398.756
• Device Catalogue Number: 398.756
• Device Lot Number: 09-5791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Received by Manufacturer: 09/26/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/06/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BONE HOOK-SHAPE ARM 206MM; SLIDING MECHANISM; SLIDING MECHANISM; SLIDING MECHANISM
• Outcome Attributed to Adverse Event: Required Intervention