MAUDE Adverse Event Report: SYNTHES GMBH HOLDING SLEEVE-LONG FOR MATRIX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.632.036
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Regarding (b)(4) the hospital indicated these ips had similar events but declined to provide any details about those events.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 during a spondylodesis procedure two instruments broke when inserting the implants.The long outer retaining sleeve broke when inserting the matrix polyaxial screw.The threaded part would not engage wholly into the head of the screw and it broke off.Another retaining sleeve was used to finish the insertion.The screwdriver also broke when locking the end caps despite being used with the torque limiting attachment.The part of the screwdriver that broke off had to be retrieved from the patient.Two (2) additional holding sleeve-long for matrix were submitted as part of this complaint since the conditions under which they broke are very similar to the events in this complaint.Concomitant devices: unknown matrix polyaxial screw (part# unknown, lot# unknown, quantity# 1), unknown end- cap (part# unknown, lot# unknown, quantity# 1).This report is for one (1) holding sleeve-long for matrix.This is report 4 of 4 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.H3, h4, h6: part number:03.632.036, synthes lot number:h148104, supplier lot number: n/a, release to warehouse date: 16jan2017, expiration date: n/a, supplier: (b)(4).A non-conformance was generated during production for 4.66 gage pin will not go.The product was returned for evaluation.Relevance to complaint condition cannot be determined until the product is returned for investigation.The received part was measured at customer quality zuchwil as part of the investigation.The non-conformance is not relevant to the complaint condition because the dimension for the received part was found to be according to specification.Visual inspection: visual inspection observed that the distal threaded tip of the returned part is partially broken without separating into 2 or more pieces.Moreover, the device is in a very used condition.The observed damage is consistent with the reported complaint condition as such the complaint condition can be confirmed.All features related to the reported complaint condition were reviewed and no other issues were identified.Dimensional inspection: a dimensional test for the thread part is not appropriate, since all complaint-relevant dimensions can no longer correspond to the valid technical drawings specifications due to the damage incurred.Feature: inner diameter.Result: pass.Document/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Summary: our investigation has shown that the complaint condition is confirmed due to the received condition of the device.Because of the damage, it is not possible to measure the relevant dimension for the threaded part.Although no definitive root-cause can be determined its possible the device encountered unintended forces such as excessive torque while in use, which finally resulted into crack at the threaded part.Moreover, all detected damages are potential end of life indicators which let us allude that this device was often and intensive used.This end of life indicators could also have had contributed to the malfunction of the device.Please find information for end of life indicators of reusable instruments.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: HOLDING SLEEVE-LONG FOR MATRIX
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10931841
• Report Number: 8030965-2020-09316
• Device Sequence Number: 13589568
• Product Code: LXH
• UDI-Device Identifier: 07611819379435
• UDI-Public: (01)07611819379435
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2020

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: 03.632.036
• Device Lot Number: H148104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 11/26/2020; 12/10/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 12/02/2020; 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RETAIN-SLEEVE LONG F/MATRIX 5.5.; RETAIN-SLEEVE LONG F/MATRIX 5.5.; SCRDRIVERSHAFT T25 LONG F/MATRIX.; UNK - END CAPS.; UNK - MATRIX POLYAXIAL SCREW.