MAUDE Adverse Event Report: SYNTHES TUTTLINGEN CURVED PELVIC OSTEOTOME 20MM WIDTH

Catalog Number	03.100.039
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: patient¿s age at time of event and/or date of birth are not available or reporting.Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: oct 17, 2011.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 during a periacetabular osteotomy (pao) on (b)(6) 2017 to treat an unknown condition, the wooden handle of the curved osteotome instrument broke from the metal portion of the device.The fragments were retrieved, no additional intervention required.A similar instrument was used to complete the procedure.No surgical delay was reported.No harm was reported to the patient.The surgery was successfully completed with the patient in stable condition.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
The device has been received and the product evaluation is in progress.No conclusion can be drawn.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
The 03.100.039 lot number 7970613 curved pelvic osteotome was returned and reported to have broken intraoperatively.This complaint condition was likely caused by over five years of consistent use and possible rough handling during surgery or sterile processing; however, this complaint is not likely a result of any design or manufacturing related deficiency.A visual inspection, dhr review, and drawing review were performed as part of this investigation.This complaint is confirmed.No new malfunctions were observed during the course of this investigation.The 03.100.039 curved pelvic osteotome is an instrument routinely used in the hip preservation surgery set (technique guide dsus/trm/0515/0603).The device was returned and reported to have broken intraoperatively.This condition is confirmed; the metal shaft of the device broke internally at the intersection of the locking pin causing the shaft to separate from the phenolic handle.It is likely that over five years of consistent use and possible rough handling during surgery and sterile processing has led to this complaint condition.The device was manufactured in 10/2011 and is over five years old.The balance of the returned device is in fairly worn condition with some markings and superficial wear along its length.Drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.Upon review of the device history record, no ncrs germane to the complaint condition were generated during the production of this device.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: CURVED PELVIC OSTEOTOME 20MM WIDTH
• Common Device Name: OSTEOTOME
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6445722
• Report Number: 9680938-2017-10058
• Device Sequence Number: 874778
• Product Code: HWM
• UDI-Device Identifier: 10886982070883
• UDI-Public: (01)10886982070883(10)7970613
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2017

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: 03.100.039
• Device Lot Number: 7970613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/13/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 04/19/2017; 05/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 118