MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM UNIVERSAL DRILL GUIDE

Model Number	323.36
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device returned.A review of the device history record.Part: 323.360, lot: 1l95154, manufacturing site: (b)(4), release to warehouse date: 26.Nov.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified investigation summary background: it was reported on an unknown date, during an unknown procedure, the two (2) universal drill guide were defective.It is unknown if there was surgical delay.Procedure and patient outcome are unknown.This complaint involves two (2) devices.Service and repair evaluation: the customer reported the device was defective.The repair technician reported the drill sleeve is damaged.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Investigation flow: damage.Visual inspection: the 3.5mm universal drill guide (p/n 323.36 lot 1l95154) was received showing the 3.5mm drill sleeve distal cannulation deformed.The distal cannulation no longer holds a circular cannulation but rather an ovular shape.No other issues were identified with the returned components of the device.Document/specification review: the following drawings, reflecting the manufactured and current revision, were reviewed.3.5mm universal drill guide 323_36 rev f/g, 3.5mm drill sleeve 323_36_6 rev a, the part was released to warehouse 26nov2018 but matches design conformity to 323_36 rev f.The material disposition was use as-is for 323.36 rev f to g, the device was manufactured prior to 07feb2018 (rev g).During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed as the 3.5mm universal drill guide (p/n 323.36 lot 1l95154) was received showing the 3.5mm drill sleeve distal cannulation deformed.No definitive root cause could be determined.It is possible that unintended/excessive forces and/or rough handling contributed to the condition.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 on an unknown date, during an unknown procedure , the two (2) universal drill guide were defective.It is unknown if there was surgical delay.Procedure and patient outcome are unknown.This complaint involves two (2) devices.This report is 1 of 2 for (b)(4).

• Brand Name: 3.5MM UNIVERSAL DRILL GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9253170
• Report Number: 2939274-2019-61819
• Device Sequence Number: 2311358
• Product Code: FZX
• UDI-Device Identifier: 10886982190826
• UDI-Public: (01)10886982190826
• 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): 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 323.36
• Device Catalogue Number: 323.36
• Device Lot Number: 1L95154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 10/29/2019
• Patient Sequence Number: 1