MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PELVIC ARM 225MM; FORCEPS

Catalog Number	398.753
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Misassembly by Users (3133)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.A review of the device history records has been requested.Device was used for treatment, not diagnosis.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, during an unknown procedure, the pelvic arm could only be removed by force after connecting the collinear reduction clamp sliding mechanism.It was unknown if there was a procedure or patient involvement.Concomitant devices reported: percutaneous arm, 255mm (part #: 398.754, lot #: 1515783, quantity: 1), bone hook-sape arm, 206mm (part #: 398.756, lot #: 10-9537, quantity: 1) and hohmann-style arm, 183mm (part #: 398.752, lot #: 1515781, quantity: 1).This complaint involves four (4) devices.This report is 3 of 4 for (b)(4).
Additional Manufacturer Narrative
Reporter is a synthes employee.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
It was reported that on (b)(6), 2018, the pelvic arm, percutaneous arm, bone hook-shape arm and hohmann-style arm were difficult to remove after connecting from the collinear reduction clamp sliding mechanism.The pelvic arm was removed by force.There was no patient involvement.This report is for a pelvic arm 225mm.There are no concomitant devices.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device evaluated by mfr: part: 398.753; lot: 13-9672; manufacturing site: selzach; supplier: (b)(4); release to warehouse date: january 06, 2014.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional 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.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.

• Brand Name: PELVIC ARM 225MM
• Common Device Name: FORCEPS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7958422
• Report Number: 8030965-2018-57234
• Device Sequence Number: 941475
• Product Code: HTD
• UDI-Device Identifier: 07611819283008
• UDI-Public: (01)07611819283008
• 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): 09/28/2018

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: 398.753
• Device Lot Number: 13-9672
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 10/15/2018; 11/13/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 10/30/2018; 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1