MAUDE Adverse Event Report: SYNTHES HAGENDORF POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number	03.607.005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted, dhr review for: manufacturing location: (b)(4).Part #03.607.005, lot.9396121, manufacturing date: 10.April 2015.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 that the polyaxial screwholder broke off.Disassembling of remobilization tool is not possible.Fragments were generated, but it's unknown whether additional intervention was necessary.It is unknown where or when this event happened, but there was no patient involved.This complaint involves one parts.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Initial phone number: (b)(6).A product investigation was completed: part 03.607.005, lot 9396121: the visual inspection of the returned polyaxial head holder has shown that a part of the tip is broken off as complained.The instrument was produced in april 2015.The review of the device history record showed that there was no issue during the manufacturing of the product that would contribute to this complaint condition.Unfortunately the exact cause which has led to this occurrence could not be defined.It is likely that a mechanical overload situation caused the breakage.The exact cause which has led to this occurrence could not be defined.Inadequate handling without oiling the instrument after the sterilization process cannot be excluded.No product fault could be detected.Reportedly there was no patient involvement.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 that the tip of a polyaxial screwholder broke off generating fragments.It is unknown where or when this event happened, but there was no patient involved.

• Brand Name: POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6197173
• Report Number: 3003875359-2016-10660
• Device Sequence Number: 509467
• Product Code: LXH
• UDI-Device Identifier: 10705034712895
• UDI-Public: (01)10705034712895(10)9396121
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2016

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: 9396121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 02/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1