MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE COUPLING SCREW; MISC ORTHO SURGICAL INSTR

Model Number	357.377
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date that during the surgery the surgeon hammered on the helical blade impactor and connecting screw and both pieces separated into their individual components.All pieces were accounted for with a short surgical delay.No patient issues.Concomitant product.Unknown hammer/mallet (part# unknown, lot# unknown, quantity 1).This complaint involves two (2) devices.This is report 2 of 2 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, h4, h6: complaint is confirmed as we are able to confirm complaint description (broken) based on the received pictures.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available (information or/and material), the investigation will be updated as applicable.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.
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, h6: 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.
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: 357.377.Synthes lot: 7681974.Supplier lot: 7681974.Release to warehouse date: october 22, 2014.Supplier: (b)(4).No nonconformance reports (ncrs) were 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 connecscr f/helical blade f/tfn was received at us customer quality (cq).Upon visual inspection, it was observed that the shaft was broken near its proximal end, and the broken piece was not returned.No other issues were identified with the returned device.Dimensional inspection: dimensional analysis was completed, the outer diameter of the shaft at the fracture site was measured to be within the specification, based on drawing.Document/specification review: the following drawings were reviewed; helical blade coupling screw trochanteric fixation nail and shaft helical blade coupling screw.Conclusion: the complaint condition was confirmed as the cap of the helical blade connecting screw was broken.There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.However, the potential cause could be due to unintended forces applied to the device.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.

• Brand Name: HELICAL BLADE COUPLING SCREW
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9889864
• Report Number: 2939274-2020-01573
• Device Sequence Number: 561404
• Product Code: LXH
• UDI-Device Identifier: 10886982196088
• UDI-Public: (01)10886982196088
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/29/2020

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: 357.377
• Device Catalogue Number: 357.377
• Device Lot Number: 7681974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: 02/29/2020
• Supplement Date Received by Manufacturer: 04/06/2020; 09/11/2020; 10/09/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 04/24/2020; 09/17/2020; 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONNECSCR F/HELICAL BLADE F/TFN; IMPACTOR F/HELICAL BLADE F/TFN; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention