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

Catalog Number 03.108.005S

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent surgery for femoral fractures using the lcp pediatric condylar plate system.During the surgery, the surgeon felt something unusual with insertion, so he tried to remove the k-wire, but could not.This k-wire usually has the thread part at the tip, but it was reported that this k-wire had another thread part other than at the tip, of which the tread part is not complete.The surgery was completed with less than thirty (30) minutes delay.Patient was stable.Concomitant devices: aiming block (part: 03.108.002, lot: unknown, quantity: 1).This report is for a 2.8mm kirschner wire spade point 200mm.This is report 1 of 1 for (b)(4).

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, h6: 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 Description

Update to concomitant device reported: aiming block (part number 03.108.002, lot 9067386, quantity 1).

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.Sterile - part part: 03.108.005s, lot: 5l69784, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: august 13, 2019, expiry date: august 1, 2029.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: non-sterile-part part: 03.108.005, lot: 5l60520, manufacturing site: balstahl, release to warehouse date: july 29, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the returned wire was received jammed into the aiming block and cannot be dismantled anymore.On the wire are deep impression marks and scratches visible.One of the 2.8mm hole (where the wire got stuck) is slightly deformed at the forefront.The other 2.8mm hole of the aiming block is still in good condition.It is clearly visible that the wire was inserted inversely into the guiding block.The threads of the wire show in the opposite direction of the block.Furthermore, the tip (threaded section) of the wire is flattened.Functional test: the parts could not be separated, consequently an accurate functional test could not be performed.Dimensional inspection: checked outer diameter of the guide wire (at an undamaged section of the shaft) with caliper 3-01-19788.Shaft diameter specification 2.8mm 0/-0.10 / measured: 2.79mm = pass checked dimensions of the guiding hole (at the undamaged/functional one) of the aiming block with caliper 3-01-19788.Hole diameter specification 2.8mm +0.05/+0.10 / measured: 2.86mm = pass.Drawing specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.Failure in material or production could not be detected.Investigation conclusion: the complaint is confirmed as the wire is jammed in one of the 2.8mm holes of the guiding block as complained.Based on the provided information, it is not possible to determine the exact cause of the complained issue.However, due the visible damages (deep scratches and impression marks), we suppose that the instrument was subjected to excessive use and which most likely led to this complained issue.Furthermore, the device was inserted inversely into the guiding block which is a clear sign of use error and post manufacturing issue.A review of the dhr for the mentioned part was researched and no abnormal findings were identified.Manufacturing and inspection records and the dimensional inspections showed no deviations.The instruments met the specifications at the time of manufacturing and distributing.We can confirm that the complaint condition is not from any manufacturing non-conformity.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: 2.8MM KIRSCHNER WIRE SPADE POINT 200MM
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10162144
• MDR Text Key: 195398445
• Report Number: 8030965-2020-04214
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 07611819373037
• UDI-Public: (01)07611819373037
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.108.005S
• Device Lot Number: 5L69784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AIMING BLOCK F/SCR Ø5 F/LCP PAED-HIPPL; AIMING BLOCK F/SCR Ø5 F/LCP PAED-HIPPL