MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.8MM KIRSCHNER WIRE SPADE POINT 200MM; GUIDE

Catalog Number	03.108.005
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during an unknown procedure on (b)(6) 2018, a 2.8mm kirschner wire became stuck inside the pediatric locking compression plate (lcp) hip plate guiding block.Another unknown wire also became stuck inside another guiding block.Backup instruments were used to complete the procedure successfully with a delay of approximately 15 minutes.This report is for one (1) 2.8mm kischner wire.(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.Additional narrative: device evaluated by mfr, device manufacture date: dhr review was completed.Part: 03.108.005, lot: l786317, manufacturing site: balsthal, release to warehouse date: 26.Feb.2018.The device history record shows this lot of 250 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Device evaluated by mfr: customer quality conducted an investigation of the received photographs.Complaint is confirmed as a stuck wire is visible on the received picture.The manufacturing documents were reviewed and no complaint related issues were found.Product was not returned, therefore and only based on the pictures is no further investigation is possible.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.

• Brand Name: 2.8MM KIRSCHNER WIRE SPADE POINT 200MM
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7693563
• Report Number: 8030965-2018-55091
• Device Sequence Number: 16420953
• Product Code: FZX
• UDI-Device Identifier: 07611819847255
• UDI-Public: (01)07611819847255
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/25/2018

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: 03.108.005
• Device Lot Number: L786317
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 11/01/2018
• Patient Sequence Number: 1