MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH JOINT PREP/CHISEL/STRAIGHT NARROW/10MM WIDE; CHISEL, SURGICAL, MANUAL

Catalog Number	03.111.015
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, that the trauma foot handle did not fit into all the chisels.The device malfunction was found during inspection.No patient or procedure involvement.Concomitant devices reported: silicone handle quick coupling/short.(part number 03.111.013.Lot 3l78331, quantity 2).This report involves one (1) joint prep/chisel/straight narrow/10mm wide.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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, h4, h6: device history lot part: 03.111.015, lot: 1403186, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 08.September 2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: investigation summary: investigation selection investigation selection investigation site: cq zuchwil selected flow: functional & damaged.Visual inspection: we¿ve received one handle and one chisel back for investigation.The quick coupling of the chisel is badly worn with impression marks and deformations.The handle is otherwise in a good condition, with slight signs of use.Functional test: the complaint condition can be confirmed as it is not possible to connect the reported chisel with the returned handle.An internal functional test with another matching chisel (part 03.111.014 / lot 2501062) was performed.The chisel could be attached and detached to the handle as intended.Therefore, it can be stated that the complaint condition is directly related to the damages at the quick coupling of the returned chisel.Dimensional inspection: as this investigation is focused in the functional issue and this was covered through the functional test performed.Therefore, no measurements of the features are required.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.Summary: the complaint is rated as confirmed, since the returned chisel cannot be attached to the handle as reported.However, during our investigation we could determine that the complaint condition is directly related to the damages at the quick coupling of the chisel.Based on the age (produced in sept.2014) and condition of the device, we assume that the product was often, and intensive used instruments and the damages were caused over the years by regular wear.In this context, we would like to draw your attention on page 4 in the leaflet ¿important information¿ version se_023827 al: 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.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: JOINT PREP/CHISEL/STRAIGHT NARROW/10MM WIDE
• Common Device Name: CHISEL, SURGICAL, MANUAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10648440
• Report Number: 8030965-2020-07804
• Device Sequence Number: 3216098
• Product Code: FZO
• UDI-Device Identifier: 07611819373358
• UDI-Public: (01)07611819373358
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 10/06/2020

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: 03.111.015
• Device Lot Number: 1403186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 10/30/2020
• 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: HANDLE SHORT W/QUICK-COUPL; HANDLE SHORT W/QUICK-COUPL; HANDLE SHORT W/QUICK-COUPL; HANDLE SHORT W/QUICK-COUPL