MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTION HANDLE FOR TI CANNULATED HUMERAL NAILS-EX; MISC ORTHO SURGICAL INSTR

Model Number	03.010.054
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; 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) 2021, the patient underwent for a surgery.During the surgery, the insertion handle for humeral nail was bent and pieces to it and difficulty attaching to the insertion handle.Procedure was successful.It is unknown if there was a surgical delay.Patient status is unknown.Concomitant devices reported: unknown humeral nail (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for one (1) unk - screws: locking.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: 03.010.054, synthes lot: 5643223, supplier lot: n/a, release to warehouse date: may 17, 2008, manufactured by: brandywine.No nonconformance reports (ncrs) generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the insrt h&le for ti cann humeral nails-ex was returned and received at us customer quality (cq).Upon visual inspection, it is observed that the tips of the barrel of the device were deformed.Impact marks were observed on the surface of the device indicating signs of heavy use.No other issues were observed with the device.Functional test: a functional test of the received device could not be performed at cq as the device was received by itself.However, the complaint condition can be confirmed as the tips of the device were deformed leading to the assembly issue.Dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq due to it being post manufacturing damage.Document/specification review: the following drawings were reviewed: insertion handle (current and manufactured to).Barrel: (manufactured to).No design issues or discrepancies were found during this investigation.Investigation conclusion: the complaint is being confirmed for insrt h&le for ti cann humeral nails-ex.A definitive root cause could not be identified for the reported problem, it is possible that the device might have encountered unintended forces leading to the deformation of the tip.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 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: INSERTION HANDLE FOR TI CANNULATED HUMERAL NAILS-EX
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12781118
• Report Number: 2939274-2021-06578
• Device Sequence Number: 19760074
• Product Code: LXH
• UDI-Device Identifier: 10886982067265
• UDI-Public: (01)10886982067265
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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: 03.010.054
• Device Catalogue Number: 03.010.054
• Device Lot Number: 5643223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAILS: HUMERAL
• Patient Sex: Unknown