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

Catalog Number	398.753
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: 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.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 (b)(6) 2020,two of the arms on the collinear reduction clamp were missing the springs (not noted on the check sheets) the reduction gun was also not engaging the arm that did have a spring, and when it finally did engage it couldn¿t be removed easily.This complaint involves (4) devices.This report is for one (1) pelvic arm 225mm this report is 3 of 4 for (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.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.
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.Investigation site: cq zuchwil selected flow: device interaction / functional.Visual inspection: the visual inspection of the pelvic arm has shown that on the connection part some heavy wear marks are visible.The locking pin is missing and is not returned for an further evaluation.Functional test: the function test at zuchwil customer quality was conducted with the returned instruments with the result that the pelvic arm could be assembled / disassembled as per design intended at the collinear reduction clamp.It was possible to attach the instrument to the collinear reduction clamp without any issues and the arm did rotate at the connection part freely after attaching as required but can not locked because of the missing pin.Summary: the investigation has shown that the pelvic arm has shown that on the connection part some heavy wear marks are visible.The locking pin is missing and is not returned for an further evaluation.Due to the age of more than 17 years of the complained device a wear or use related root cause is the most likely reason of the complained malfunction.Please note: due to previously received market feedback of this failure's nature "sliding fit surfaces presents wear marks / jamming problem", this issue has been already addressed to responsible site.The returned devices were determined to have been manufactured prior to the changes implemented in capa.Capa identified design root causes of ¿material: incorrect specification (design)¿ and ¿material: dimensional interaction.¿ these root causes and the associated design and clinical risk management (dcrm) documents are addressed by capa.Thus, no further evaluation for this complaint is required.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps "dimensional inspection:, drawing/specification review: " are not required.H3, h4, h6: a device history record (dhr) review was conducted: part: 398.753, lot: 2041549, manufacturing site: bettlach, supplier: (b)(4), release to warehouse date: february 25, 2003.Due to the age of more than 17 years of the complained device a wear or use related root cause is the most likely reason of the complained malfunction.Per franchise complaint product investigation procedure is for complaints for which a non-manufacturing related probable cause has been identified no manufacturing record evaluation is required.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: 10115614
• Report Number: 8030965-2020-03904
• Device Sequence Number: 19294724
• Product Code: HTD
• UDI-Device Identifier: 07611819283008
• UDI-Public: (01)07611819283008
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2020

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: 398.753
• Device Lot Number: 2041549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 07/02/2020; 07/09/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 07/08/2020; 07/21/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COLLINEAR REDUCTION CLAMP SLIDING MECHAN; HOHMANN-SHAPE ARM F/COLLIN REDUC CLAMP; PELVIC ARM F/COLLIN REDUC CLAMP; PERCUT-ARM F/COLLIN REDUC CLAMP; COLLINEAR REDUCTION CLAMP SLIDING MECHAN; HOHMANN-SHAPE ARM F/COLLIN REDUC CLAMP; PELVIC ARM F/COLLIN REDUC CLAMP; PERCUT-ARM F/COLLIN REDUC CLAMP