MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL; MISC ORTHO SURGICAL INSTR

Catalog Number	03.607.005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review has been requested.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 europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, patient underwent the adolescent idiopathic scoliosis surgery at th5.During the surgery, the counter did not fit the screw head and the surgeon used the screw holder to hold the screw head to guide inserting the counter.After fastening the screw, it was reported that the screwdriver tip was broken when the surgeon tried to remove the driver from the holder.The broken tip remained on the top of the screw holder and could not be removed.Finally, the surgeon attached another chuck at the top of the holder, so that the surgeon could remove the broken fragment from the holder.There were no broken parts in the patient¿s body.There was less than thirty minutes surgical delay and there was no adverse consequence to the patient.Procedure was completed successfully.This report is for 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.Part: 03.607.005; lot: 3358597; manufacturing site: haegendorf; release to warehouse date: february 02, 2010.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Investigation site: cq zuchwil.Selected flow 2: device interaction / functional.Visual investigation: the uss-ii polyaxial screw holder is intact; nothing is broken off or bent, and the threads on both components also are not damaged.The guide tube as well as the connecting screw are fully functional.The knurled knob of the connecting screw shows marks of an unknown instrument, presumably caused from some forceps.Functional test : the two components of the uss-ii polyaxial screw holder can be unscrewed and reassembled without any problems.Dimensional inspection : a dimensional inspection is not appropriate as the device is fully functional and as per event description there is no allegation against the device.Document/specification review : a document/specification review is not appropriate as the device is fully functional and as per event description there is no allegation against the device.Conclusion: as per received event description there is no allegation against the uss-ii polyaxial screw holder.The device functioned as per intended use but the tip from the used screw driver broke off in the hexagon socket of the head on the connection screw and later was removed with a chuck.The two components of the uss-ii polyaxial screw holder can be unscrewed and reassembled without any problems.The visible marks on the knurled knob point to the fact that the device was subjected to mechanical misuse, nevertheless it is fully functional.The complaint therefor is not confirmed.No manufacturing related issue was identified and/or confirmed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7794235
• Report Number: 8030965-2018-55797
• Device Sequence Number: 11085964
• Product Code: LXH
• UDI-Device Identifier: 07611819185418
• UDI-Public: (01)07611819185418
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/01/2018

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: 3358597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1