MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SHAFT FOR TREPHINE ATTACHMENTS

Model Number	03.111.030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date, the patient underwent an unknown surgical procedure for unknown reason.During use of the bone harvesting shaft, the tip broke.The procedure was successfully completed.It was unknown if there was surgical delay.Patient outcome was unknown.This report is for one (1) shaft for trephine attachments.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Initial reporter is synthes sales representative without a lot number the device history records review could not be completed.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, 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.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: the complaint device shaft for trephine attachments (product code: 03.111.030, lot number: 1l23697) was returned to cq west chester for investigation.The prongs on the shaft were broken and returned along with the shaft.Document /specification review: based on the date of manufacture, the current and manufactured version of the drawings were reviewed.Dimensional inspection: complaint relevant dimension cannot be measured due to post manufacturing damage.Conclusion: the shaft was returned broken.A definitive root cause was not determined during investigation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.H3, h4, h6: a device history record (dhr) review was conducted: part: 03.111.030.Lot: 1l23697.Manufacturing site: bettlach.Release to warehouse date: 20.Nov.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The material was reviewed and the hardness value was confirmed to meet the specification with no non-conformance noted.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 further reported that broken fragments were removed.There was no surgical delay.Procedure outcome is reported as successful.

• Brand Name: SHAFT FOR TREPHINE ATTACHMENTS
• Common Device Name: TREPHINE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13052010
• Report Number: 2939274-2021-07179
• Device Sequence Number: 3951756
• Product Code: HWK
• UDI-Device Identifier: 10886982072283
• UDI-Public: (01)10886982072283
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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: 03.111.030
• Device Catalogue Number: 03.111.030
• Device Lot Number: 1L23697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown