MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STRAIGHT TIP T25 DRIVER STANDARD; SCREWDRIVER

Model Number	03.632.400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a synthes employee.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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 on an unknown date that the distal tip of two screwdrivers was broke upon final tightening of the screw.All tip fragments were retrieved, and no pieces remained in the patient.Also, a matrix threaded holding sleeve distal tip sheared when attempting to re-engage the pedicle screw, but piece did not fall off.The surgery was completed without any delay.There was no patient consequence.Concomitant devices reported: unknown matrix spine locking cap (part# unknown, lot# unknown, quantity# 1).Unknown pedicle screw (part# unknown, lot# unknown, quantity# 1).This is report 01 of 03 of (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: part: 03.632.400; lot: l463379; manufacturing site: haegendorf; release to warehouse date: august 29, 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the scrdrivershaft t25 std straight tip w/he (p/n: 03.632.400, lot number: l463379) was received at us customer quality (cq).Upon visual inspection, the tip of the screwdriver is broken off.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post manufacturing damage.Document/specification review: current and manufactured was reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the screwdriver tip has broken off.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.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.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: d10 h3, h4, h6: part 03.632.400, lot l463379: manufacturing site: haegendorf.Release to warehouse date: august 29, 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.H3, h6: a product investigation was completed: upon visual inspection, the tip of the screwdriver is broken off.No dimensional inspection can be performed due to post manufacturing damage.The relevant drawings were reviewed; no design issues or discrepancies were identified.This complaint is confirmed as the screwdriver tip has broken off.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.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.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.

• Brand Name: STRAIGHT TIP T25 DRIVER STANDARD
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9739145
• Report Number: 2939274-2020-00963
• Device Sequence Number: 2475072
• Product Code: HXX
• UDI-Device Identifier: 10705034719917
• UDI-Public: (01)10705034719917
• 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,Followup,Followup
• Report Date (Section B): 01/29/2020

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: 03.632.400
• Device Catalogue Number: 03.632.400
• Device Lot Number: L463379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/12/2020; 04/20/2020; 03/25/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/26/2020; 04/20/2020; 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RETAIN-SLEEVE LONG F/MATRIX 5.5; SCRDRIVERSHAFT T25 STD STRAIGHT TIP W/HE; SCRDRIVERSHAFT T25 STD STRAIGHT TIP W/HE; UNK - LOCKING/SET SCREWS: MATRIX; UNK - SCREWS