MAUDE Adverse Event Report: SYNTHES BRANDYWINE OPAL IMPLANT HOLDER PISTOL GRIP; MISC ORTHO SURGICAL INSTRUMENT

Model Number	03.803.002
Medical Device Problem Codes	Break (1069); Unintended Movement (3026)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.No patient involvement reported.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.A service & repair evaluation/review was attempted; s&r service history review request for part 03.803.002, lot 5624343: no service history review can be performed as part number 03.803.002 with lot number(s) 5624343 is a lot/batch controlled item.The manufacture date of this item is 3-mar-2008.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Service and repair evaluation : the customer reported the handle was broken.The repair technician reported the shaft of the implant holder was coming loose out of the handle.Handle cracked/broken is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Device history records review was conducted.The report indicates that the: dhr review for part # 03.803.002, synthes lot # 5624343 release to warehouse date: 03-mar-2008.Expiration date: na.Manufactured by: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.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
The service and repairs department documented that an opal implant holder pistol grip handle is broken.Issue found during inspection of set.This complaint involves one device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Customer quality (cq) engineering investigation: visual inspection: opal implant holder (p/n 03.803.002) was returned at cq location with the handle in a loose condition.The handle was found to be displaced downwards from its ideal position hence is wobbling.This will interfere with the proper functioning of the device.Knob and shaft were not returned with the complaint.The balance of the returned device is in slightly worn condition with superficial wear marks all over the device surface.The device is approx.9 years old.The complaint condition is most probably a result of cumulative wear of the device during such a long time of usage combined with a possible malhandling of the device either during surgery or sterilization process.Replication of the complaint condition could not be performed at cq location due to confirmed damage to the device.No other damage was observed.Visual inspection, device history record (dhr) review, service & repair evaluation and drawing review were performed as part of this investigation.This complaint is confirmed.Device 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: OPAL IMPLANT HOLDER PISTOL GRIP
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6970437
• Report Number: 2530088-2017-10318
• Device Sequence Number: 19135370
• Product Code: LXH
• UDI-Device Identifier: 10705034722450
• UDI-Public: (01)10705034722450(10)5624343
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2017

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 Model Number: 03.803.002
• Device Catalogue Number: 03.803.002
• Device Lot Number: 5624343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1