MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH RETAIN-SLEEVE STD F/MATRIX 5.5; MISC ORTHO SURGICAL INSTR

Catalog Number	03.632.001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Date of event is unknown.Device is an instrument and is not implanted/explanted.Telephone number and address unknown.A device history record review was requested.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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, a surgery for degenerative lumbar spondylolisthesis was performed.The fixed area was l3-l5.During the surgery, the surgeon successfully inserted the screw by using the connected two devices.Then, he found that the thread part of retain sleeve was broken.As the screw insertion was successfully done, he completed the surgery without any delay.No broken parts were found left in the body, and there was no adverse consequence to the patient.There is no complaint against the screwdriver.The procedure was successfully completed.Concomitant parts: unknown quantity of unknown screws, 1 qty, part number 03.632.005, lot number unknown.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.Facility address and phone number are known.Dhr review: part: 03.632.001; synthes lot: 6624740; supplier lot: 596692g08; release to warehouse date: january 01, 2011; supplier: magnum manufacturing center, inc.; manufacturing site: monument; no nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Investigation selection investigation site: cq zuchwil; selected flow: 5.Broken visual inspection: the received retaining sleeve shows that the half of the first two threads are broke off from the distal tip.Furthermore, the whole device is in a very used condition.The broken off portion is missing.Dimensional inspection: not required per selected investigation flow as root cause is use related.In addition, because of the damages, the complaint relevant dimensions cannot be checked to print specifications anymore.Drawing/specification review: not required per selected investigation flow as root cause is use related.Material review: the material review was performed during the device history review and meets the specification.Summary: the received condition of the device is concordant with the complaint description and the complaint condition is confirmed.Based on the provided information, we are not able to determine the exact cause of this complaint.We assume that the threads of the retaining sleeves were damaged by a loose prime lock connection between the retaining sleeve and the screw during the insertion.Such a loose connection, in combination with high lateral stress, can lead to a breakage of the thread.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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: RETAIN-SLEEVE STD F/MATRIX 5.5
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7439586
• Report Number: 8030965-2018-53182
• Device Sequence Number: 13739183
• Product Code: LXH
• UDI-Device Identifier: 07611819378056
• UDI-Public: (01)07611819378056
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2018

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: 03.632.001
• Device Lot Number: 6624740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1