MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH ROD HOLDING FORCEPS FOR 5.5MM RODS

Catalog Number	03.632.081
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2018
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.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, the surgery for l4 limbus vertebra was performed by using the matrix 5.5 system.The fixed area was t10 ¿ l4.When the instrument was checked on (b)(6) 2018, it was felt that the ratchet for the rod folder has much play and was easily detached.The surgeon pointed out that this issue happened during the operation on (b)(6) 2018.The surgery was completed with no delay, and there was no adverse consequence to the patient.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.Device history records review was completed for part# 03.632.081, lot# t957448.Manufacturing location: tuttlingen, release to warehouse date: feb 11, 2011.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 development investigation was completed.The returned instrument was examined and the complaint condition could be replicated as the locking mechanism could not be locked securely.The teeth of the locking mechanism are worn and are the reason for this event.The device was manufactured and distributed in 2011 and hence subjected to frequent use.The device history records review showed that the device met fully to the specifications at the time of manufacturing in february 2011 and there were no issues that would contribute to this complaint condition.End of life of a device is normally determined by wear and damage due to use.Evidence of damage and wear on a device may include but is not limited to corrosion (i.E.Rust, pitting), discoloration, excessive scratches, flaking, wear and cracks.Improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed off) part numbers, damaged and excessively worn devices should not be used.No manufacturing related issues were found.The root cause is determined to be normal wear and tear.Based on the investigation findings, it has been determined that no corrective and/or preventative action is appropriate.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: ROD HOLDING FORCEPS FOR 5.5MM RODS
• Common Device Name: FORCEPS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7303520
• Report Number: 8030965-2018-51526
• Device Sequence Number: 1328372
• Product Code: HTD
• UDI-Device Identifier: 07611819412552
• UDI-Public: (01)07611819412552(10)T957448
• 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): 02/05/2018

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: 03.632.081
• Device Lot Number: T957448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1