MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH MEDIUM CABLE PASSER; MISC ORTHO SURGICAL INSTR

Catalog Number	391.105
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not expected to be returned for manufacturer review/investigation.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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) 2019, an unknown surgery for the femoral trochanteric fracture was performed with two (2) cable passers.During the surgery, the surgeon could not thread the cables into the passers' hole.Subsequently, a blackish brown colored foreign material came out from the holes of passers.The surgeon suspected the insufficiency of the cleaning before the device was shipped.The surgery was delayed by less than 30 minutes.The surgery was completed successfully.There was no adverse consequence to the patient.Concomitant device: cable (part unknown, lot unknown, quantity 1).This report is for one (1) cable passer.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The review of the provided photos shows some black residues as reported in the complaint description.We are not able to identify the source of those residues.However, as the devices are several years old and seems to be often used, inadequate cleaning and maintenance after prior use maybe most probably the root cause for the detected residues.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: device history lot : part # 391.105.Synthes lot # p174338.Supplier lot # p174338.Release to warehouse date: 17 mar 2014.Supplier: (b)(4).No ncr's were generated during production.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: MEDIUM CABLE PASSER
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8378866
• Report Number: 8030965-2019-61574
• Device Sequence Number: 193285
• Product Code: LXH
• UDI-Device Identifier: 07611819719743
• UDI-Public: (01)07611819719743
• 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,Followup
• Report Date (Section B): 02/07/2019

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: 391.105
• Device Lot Number: P174338
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 04/03/2019; 04/05/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 04/03/2019; 04/29/2019
• 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: SEE EVENT DESCRIPTION