MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS

Model Number	357.369
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
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 an unknown date during routine incoming inspection, the guide sleeve for helical blade for trochanteric femur nail (tfn) was broken.There was no patient involvement.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.Flow: damage.Visual inspection: it was noticed that the device had severe scratches, nicked and dent marks on the body.Further observation reveals that the inner threads side at proximal end and outer threads were found to be worn/stripped/deformed.The yellow color coding at head was worn too.But there was nothing found physically broken off the device.Hence, the complaint can not be confirmed for the broken condition.Conclusion: the complaint is not confirmed.After a visual inspection per guidance provided in windchill document # (b)(4), it is determined that the device is worn from repeated use and servicing during its 15+ years lifespan; therefore, further investigation for the reported complaint device is not required.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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 history lot.Part # 357.369.Synthes lot # 4571088.Supplier lot # na.Release to warehouse date: mar 23, 2004.Manufactured by synthes brandywine.Mrr # (b)(4) was generated for the go gage 60265a does not go on.Device was reinspected and deemed use as is because parts oversized by microns, passed functional straightness gage.Does not affect safety or efficacy of the device.Ref mrr (b)(4).Device history review.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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: BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9316420
• Report Number: 2939274-2019-62150
• Device Sequence Number: 16283648
• Product Code: FZX
• UDI-Device Identifier: 10886982196033
• UDI-Public: (01)10886982196033
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 10/28/2019

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: 357.369
• Device Catalogue Number: 357.369
• Device Lot Number: 4571088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1