MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH ALUMINUM HOHMANN RETRACTOR 18MM WIDTH

Catalog Number	03.100.109
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier, age or date of birth, and weight not available for reporting.(b)(4).Lot unknown.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.Initial reporter is synthes affiliate without a lot number the device history records review could not be completed.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 the aluminum hohmann retractor was used during a procedure to repair a femoral trochanteric fracture on (b)(6) 2017.Surgery was completed successfully with no delay.After the procedure the staff was washing and inspecting the device and noticed that the tip of the retractor was broken.It is not known if the device broke intraoperatively or postoperatively.No confirmation was made to determine if the broken tip remains in the patient.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Device history record review.Part number: 03.100.109.Synthes lot number: 9980952.Supplier lot number: n/a.Release to warehouse date: 15-apr-2016.Expiration date: n/a.Supplier: (b)(4).No ncrs were generated during production.Investigation was investigation was completed by supplier, (b)(6) medical which is part of integer.The material met the requirements of al6061tb.Dimensional analysis was completed.Some dimensions are specified in a flat condition; part is deformed.Some measurements could not be taken due to the damage condition of the returned part.Device history record review showed no ncrs were generated during production.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not applicable.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ALUMINUM HOHMANN RETRACTOR 18MM WIDTH
• Common Device Name: RETRACTOR
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7178379
• Report Number: 8030965-2018-50215
• Device Sequence Number: 16456329
• Product Code: GAD
• UDI-Device Identifier: 07611819302303
• UDI-Public: (01)07611819302303(10)LOTUNKNOWN
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2017

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: 03.100.109
• Device Lot Number: 9980952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 01/15/2018; 03/12/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 01/31/2018; 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1