MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH POLYAXIAL HEAD ALIGNMENT TOOL FOR MATRIX; MISC ORTHO SURGICAL INSTR

Catalog Number	03.632.007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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 both the positioning instrument for polyaxial screw heads (03.632.037) and the toothed rack retractor (03.632.087) were not functioning properly.The positioning instrument has broken into two pieces, and the toothed rack retractor is not ratcheting properly.A matrix pedicle screw system, which is consigned to university hospital southampton, orthopedic theaters.It was unknown if there was surgical delay.There was no patient consequence.This is 1 of 1 for report (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.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 ALIGNMENT TOOL FOR MATRIX
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9788444
• Report Number: 8030965-2020-01650
• Device Sequence Number: 19387209
• Product Code: LXH
• UDI-Device Identifier: 07611819379206
• UDI-Public: (01)07611819379206
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 02/10/2020

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 Catalogue Number: 03.632.007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALIGNMENT TOOL F/POLYAX SCREWHEAD F/MATR; TOOTHED RACK RETRACTOR F/MATRIX