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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Product was not returned and therefore, no further investigation is possible.Reviewing attached picture, the breakage can be confirmed.The breakage point was found on the tip of the device.The broken fragments are not visible.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the top of the uss ii polyaxial driver broke off.There was no surgery delay.The surgery was completed successfully with another available instrument.There was no adverse patient harm.This report involves one (1) polyaxial head holder for uss polyaxial.This is report 1 of 1 for (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.H10 additional narrative: d4; d9 h3, h6: a product investigation was conducted.Visual inspection: the uss-ii polyax scrholder (p/n: 03.607.005, lot #: l507771) was returned and received at us cq.Upon visual inspection, it was observed that the tip of the device was broken and the broken fragments were not returned.The connecting screw component was missing from the device.No other issues were identified.Dimensional inspection: specified dimensions: shaft diameter measured dimensions: shaft diameter =conforming document/specification review: the relevant documents were reviewed: no design issues or discrepancies were identified.Investigation conclusion: the complaint condition was confirmed as the tip of the device was broken.No definitive root cause could be determined based on the provided information.The unintended forces might have contributed to the reported complaint condition.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.H3, h4, h6: a device history record (dhr) review was conducted: part: 03.607.005 lot: l507771 manufacturing site: hägendorf release to warehouse date: 29.Sep.2017 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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
• MDR Report Key: 11562913
• Report Number: 8030965-2021-02257
• Device Sequence Number: 11957327
• Product Code: LXH
• UDI-Device Identifier: 07611819185418
• UDI-Public: (01)07611819185418
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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 Catalogue Number: 03.607.005
• Device Lot Number: L507771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1