MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BONE HARVESTING TREPHINE STYLET

Model Number	03.111.031
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device received.A review of the device history record.Device history lot: part: 03.111.031.Lot: l227486 manufacturing site: (b)(4).Release to warehouse date: 23.Dec.2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary background: it was reported on an unknown date that bone harvesting trephine stylet was found bent when putting up set.There is no patient involvement.This complaint involves (1) patient.Investigation flow: damage.Visual inspection: the bone harvesting trephine stylet (p/n 03.111.031.Lot l227486).Was received showing the shaft bent.No other issues were identified.Dimensional inspection: drawing: stylet trephine orthopedic foot se_195176 rev c.Document/specification review: the following drawings, reflecting the manufactured and current revision, were reviewed.Stylet trephine orthopedic foot se_195176 rev c/d 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 for the bone harvesting trephine stylet (p/n 03.111.031 lot l227486) as the shaft was bent.While no definitive root cause could be determined, it is possible that the device encountered unintended bending forces.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
It was reported on an unknown date that bone harvesting trephine stylet was found bent when putting up set.There is no patient involvement.This complaint involves (1) patient.This report is 1 of 1 for.

• Brand Name: BONE HARVESTING TREPHINE STYLET
• Common Device Name: TREPHINE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8983282
• Report Number: 2939274-2019-60429
• Device Sequence Number: 2837517
• Product Code: HWK
• UDI-Device Identifier: 10886982072290
• UDI-Public: (01)10886982072290
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/13/2019

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: 03.111.031
• Device Catalogue Number: 03.111.031
• Device Lot Number: L227486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/10/2019
• Patient Sequence Number: 1