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

Catalog Number	391.105
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: initial reporter is synthes sales representative.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) 2018, a brown liquid was leaking from the ferrocell handle of five (5) cable passers (different sizes) at the cleaning and sterilization process.There was no patient involvement.This report is for one (1) medium cable passer.This is report 3 of 5 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: device history records review was completed for part: 391.105, lot: p159810.Supplier: pioneer surgical technology, release to warehouse date: aug 28, 2013.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed.The returned cable passers are in a used, but still in a very good conditions and fully functional.Only different darkening of the handles are visible and no signs of more severe degradation, such as bleeding or erosion were found.The device history records shows these lots were processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lots met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.The returned cable passers are in a used, but still in a very good conditions and fully functional.Only different darkening of the handles are visible and no signs of more severe degradation, such as bleeding or erosion were found.Therefore, the complaint is classified as non confirmed.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.
Event or Problem Description
Device report from synthes reports an event in germany as follows: it was reported that on an unknown date, it was noted that a brown liquid was leaking from the ferrocell handle of five (5) cable passers (different sizes) at cleaning and sterilization process.The problem is existing since a long time, and is repeated on a regular basis.There was no patient involvement.This is report 3 of 5 for (b)(4).

• 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: 8219548
• Report Number: 8030965-2019-59470
• Device Sequence Number: 264721
• Product Code: LXH
• UDI-Device Identifier: 07611819719743
• UDI-Public: (01)07611819719743
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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: 391.105
• Device Lot Number: P159810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1