MAUDE Adverse Event Report: SYNTHES GMBH POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.607.005
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in the (b)(6) as follows: it was reported that on (b)(6) 2022, during final tightening of the polyaxial screws there was an unusual "screeching" sound while tightening the nuts.This occurred with approximately 50% of screws.The surgeon commented that it sounded like the screws were cross threading in a similar way to previous issues the surgeon had had with the uss polyaxial heads.This noise was not observed with the monoaxial screws used.Final tightening was achieved and there was a ten (10) minute delay to the case.During final tightening item the uss-ii polyaxial screwholder broke off in one of the screw heads leaving a small threaded portion in the screw head.The fragment was retrieved causing approximately a ten (10) minute delay to the surgery.This report involves one (1) polyaxial head holder for uss polyaxial.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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.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, h4, h6: part 03.607.005, lot 8955160: manufacturing site: werk hagendorf.Release to warehouse date: june 25, 2014.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.H3, h6: a product investigation was completed: visual analysis of the returned sample revealed that the threaded distal end of the inner shaft of the uss-ii polyaxial screwholder was broken.The broken fragment was not returned for evaluation.No other product problems identified.No dimensional inspection was performed due to post-manufacturing damage.Complaint relevant dimensions cannot be taken.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as mentioned in the event description.The current and manufactured to drawings were reviewed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the device would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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: POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13757104
• Report Number: 8030965-2022-01575
• Device Sequence Number: 17579983
• Product Code: LXH
• UDI-Device Identifier: 07611819185418
• UDI-Public: (01)07611819185418
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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
• Device Catalogue Number: 03.607.005
• Device Lot Number: 8955160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: POLYAXIAL 3D-HEAD F/R Ø6 TAN GREE; USS-II POLYAX SCRHOLDER; USS-II POLYAX SCRHOLDER; USS-II POLYAX SCRHOLDER; USS-II POLYAX SCRHOLDER; USS-II POLYAX SCRHOLDER; USS-II POLYAX SCRHOLDER; USS-II POLYAX SCRHOLDER; USS-II POLYAX SCRHOLDER; USS-II POLYAX SCRHOLDER; USS-II POLYAX SCRHOLDER
• Patient Sex: Unknown