MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC THREADED PLATE HOLDER-LONG FOR 3.5MM LOCKING HOLE; GUIDE

Model Number	324.031
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device deemed reportable on september 19, 2019 as a result of investigation.Initial reporter is company representative.Investigation summary: visual inspection: the pl-holder ø3.5 long (p/n 324.031 lot 8716407) was received with the distal threads stripped, flattened, and nicked.No other issues were identified with the returned device.The stripped and nicked threads of the plate holder is a potential end of life from normal wear and consistent use over the part¿s lifetime.Conclusion: after a visual inspection per guidance provided in windchill document # (b)(4), it is determined that the reusable instrument is worn from repeated use and servicing (5+ years); therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part: 324.031.Lot: 8716407.Manufacturing site: (b)(4).Release to warehouse date: 20.Dec.2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 a threaded plate holder is defective.No known surgical or patient involvement.This is report 1 of 1 for (b)(4).

• Brand Name: THREADED PLATE HOLDER-LONG FOR 3.5MM LOCKING HOLE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9129875
• Report Number: 2939274-2019-60960
• Device Sequence Number: 2452243
• Product Code: FZX
• UDI-Device Identifier: 10886982190987
• UDI-Public: (01)10886982190987
• 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
• Report Date (Section B): 07/02/2019

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: 324.031
• Device Catalogue Number: 324.031
• Device Lot Number: 8716407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1