MAUDE Adverse Event Report: SYNTHES GMBH CLAMP HOLDER FOR USS ILIOSACRAL; MISC ORTHO SURGICAL INSTR

Catalog Number	03.621.011
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, 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 that on (b)(6) 2020 during a pelvis fusion in the ilium procedure, the tip of the screw holder broke off during final screw tightening.The fragment was easily removed and the procedure was successfully completed.There was a surgical delay of less than thirty (30) minutes.The patient outcome was reported as stable.There is no further information available.This report is for one (1) clamp holder for uss iliosacral.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.A product investigation was conducted.Visual inspection: the visual inspection of the clamp hold has shown that the threaded tip of connection screw (50164594) is broken off.Further investigation has also shown that the broken threaded tip is damaged / stripped.Dimensional inspection: the relevant feature is deformed in a manner which prevents accurate measurement of the feature.A functional test can not be performed of the detected damage.Document/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.This broken connection screw was made from the sub-component (50164594).The component is not lot tracked.Therefore, the potential work order that was produced prior to lot 3505680 were reviewed.The review has shown that with raw materials 1.4028 the correct material was used.The measurements of the hardness after the hardening procedure were within the specification per relevant drawing.Summary: the complaint is confirmed as the the threaded tip of connection screw (50164594) is broken off.This production lot (3505680) was manufactured in july 2010 according to the specification.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.There were no issues during the manufacture of this product that would contribute to this complaint condition.Based on these findings, the age and the very used a condition of the threaded broken connection screw tip a manufacturing related issue can be excluded.Therefore we have to assume that simply too much applied mechanical force, well beyond its calculated design caused the breakage of the threaded tip.In this relation, we would like to point out that further hints concerning the limits of reprocessing (e.G.End of life of a device) can be found in the important information leaflet se_023827_am.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.A device history record (dhr) review was conducted: part number: 03.621.011, lot number: 3505680, manufacturing site: haegendorf, release to warehouse date: 15.July 2010.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: CLAMP HOLDER FOR USS ILIOSACRAL
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10886013
• Report Number: 8030965-2020-09130
• Device Sequence Number: 2829402
• Product Code: LXH
• UDI-Device Identifier: 07611819194922
• UDI-Public: (01)07611819194922
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

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: 03.621.011
• Device Lot Number: 3505680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1