MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.5MM WIRE GUIDE FOR 5.0MM SCREWS

Model Number	324.174
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that screwdriver could not be inserted into hex.No other information has been provided.This report is for one (1) 2.5 mm wire guide for 5.0 mm screws.This is report 1 of 2 for complaint (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.A review of the device history record part # 324.174, synthes lot number: 5015050, manufacturing site: synthes brandywine , release to warehouse date: 21-mar-2013, no ncr¿s were generated during production.Device history batch null, device history review 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.H3, h6::investigation summary background: bq received a device from the customer.Issue reported that cannot insert screwdriver into hex.No other information has been provided.This complaint involves (2) devices.Investigation flow: device interaction/functional.Visual inspection: the 2.5mm wire guide for 5.0mm screws was received at the us cq.The device was in good condition with slight surface wear.On closer inspection of the drive recess, there was observed a few outward dents and edge deformities, but none were too big or in important areas so as to remove functionality.No other issues could be identified with the returned portions of the device.Functional test: a functional test was performed on the 2.5mm wire guide for 5.0mm screws using an unassociated t-handle with ratchet wrench and hexagonal coupling (part # 03.632.090).The t-handle¿s distal tip was able to securely interface with the wire guide¿s drive recess.Document/specification review: 2.5mm wire guide for 5.0mm screws; 324_174 rev j & g.Manufacturing record evaluation: the received device (part # 324.174 lot # 5015050) was manufactured at the synthes brandywine site on 21 march 2013.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.Conclusion: the complaint could not be confirmed for the 2.5mm wire guide for 5.0mm screws.The device had some deformities in its drive recess, however, it was able to function as intended during the functional test.The associated screwdriver was not received, so it is unclear whether the screwdriver or the wire guide was the cause of the complaint.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.No definitive root cause could 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.

• Brand Name: 2.5MM WIRE GUIDE FOR 5.0MM SCREWS
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8842254
• Report Number: 2939274-2019-59442
• Device Sequence Number: 3011972
• Product Code: FZX
• UDI-Device Identifier: 10886982191151
• UDI-Public: (01)10886982191151
• 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
• Report Date (Section B): 07/03/2019

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: 324.174
• Device Catalogue Number: 324.174
• Device Lot Number: 5015050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1