MAUDE Adverse Event Report: SYNTHES GMBH RAD AIMING ARM/FRN PIRIFORMIS FOSSA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	03.033.002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2023
Type of Reportable Event	Malfunction
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6 the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample found one of the plastic tabs broken.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the [rad aiming arm/frn piriformis fossa] would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed the following drawings reflecting the current and manufactured revisions were reviewed: dwg se_676301 rev b manufactured / rev c current dimensional inspection: n/a product code: 03.033.002.Lot number: l551657.Release to warehouse date : 09 nov 2017.Expiration date : na.Supplier: na.Manufacturing site: werk hagendorf.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 on (b)(6) 2023, that, while drilling for the recon screw, the tip of the drill bit broke off on the medial (far) side of the nail.The decision to back the nail up and re-drill was made.While back slapping the nail the driving cap broke at the thread shaft junction.There was a surgical delay for 10-15 mins.The surgery was successfully completed.Concomitant product details: unk - nails (part # unknown, lot # unknown, quantity - unknown), unk - screws: trauma (part # unknown, lot # unknown, quantity - unknown).This report is for one (1) rad aiming arm/frn piriformis fossa.This is report 3 of 3 for complaint (b)(4).

• Brand Name: RAD AIMING ARM/FRN PIRIFORMIS FOSSA
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HAGENDORF; im bifang 6; hagendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17367137
• Report Number: 8030965-2023-09052
• Device Sequence Number: 7361544
• Product Code: HSB
• UDI-Device Identifier: 10886982271068
• UDI-Public: (01)10886982271068
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• 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: Other Health Care Professional
• Type of Report: Initial

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: 03.033.002
• Device Catalogue Number: 03.033.002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.5/6.5 STEPPED DRILL BIT LARGE QC/485; DRIVING CAP/THREADED; RADIOLUCENT INSERTION HANDLE FRN; UNK - NAILS; UNK - SCREWS: TRAUMA
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 83 KG