MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOHMANN-STYLE ARM 183MM; FORCEPS

Model Number	398.752
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, and the product evaluation is in progress.No conclusion can be drawn.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) 2019, during open reduction internal fixation (orif) left distal femur fracture, the hohmann-style arm broke as the surgeon was trying to reduce the femur fracture.The surgeon used a different reduction clamp to reduce the fracture and the holes in the multiple wire guide were not parallel.The surgeon inserted the 2.8 wires free hand to get the path he wanted.There was two to three (2-3) minutes delay in the surgery.The patient outcome was good.  concomitant devices: threaded guide wire (part unknown, lot unknown, quantity 1).This report is for one (1) hohmann style arm.This is report 1 of 1 for (b)(4).
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.H3, h6: part: 398.752; lot: 13-2513; manufacturing site: selzach; supplier: leitner ag; release to warehouse date: april 15, 2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Correct material used for all components is documented in certificate of conformance (coc) from supplier.Visual inspection: visual inspection performed at customer quality observed that the hohmann-style arm 183mm was broken at the welded joint.The broken surface appears homogeneous with no voids or dark spots.No sign of damage was observed on the remaining portions of the device except slightly worn surfaces which would not impact the device functionality.The received condition agrees with the complaint description.This complaint confirmed.Dimensional inspection: dimensional inspection of the hohmann-style arm 183mm (398.752) cannot be performed due to the post manufacturing damage.Document/specification review: relevant drawings for the returned device, hohmann-style arm 183mm were reviewed, and no design issues were found which can contribute to this complaint condition.Design history record (dhr) and material review or hardness review: a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Correct material used for all components is documented in coc from supplier.Conclusion: a visual inspection and document/specification review were performed as part of this investigation.The complaint device hohmann-style arm 183mm was observed to be broken at welded junction, thus confirming the complaint.While a definitive root cause could not be identified that contributed to the complaint condition.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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.

• Brand Name: HOHMANN-STYLE ARM 183MM
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8383188
• Report Number: 2939274-2019-56762
• Device Sequence Number: 16560034
• Product Code: HTD
• UDI-Device Identifier: 10886982201560
• UDI-Public: (01)10886982201560
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019

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 Model Number: 398.752
• Device Catalogue Number: 398.752
• Device Lot Number: 13-2513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 87