MAUDE Adverse Event Report: SYNTHES TUTTLINGEN INSERTER-MEDIUM; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number	PDL402
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Additional narrative: event date: unknown.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; no service history review can be performed as part number pdl402 with lot number(s) 5313925/a7oa47 is a lot/batch controlled item.The manufacture date of this item is 30-mar-2007.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Device history records review was attempted /requested.The report indicates that: dhr review for: manufacturing location: synthes (b)(4), packaged by -(b)(4) manufacturing date: 30-mar-2007; part #: pdl402, lot#: 5313925 (non-sterile) inserter - medium quantity 2.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the 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
Service and repair department documented synthes evaluation equipment (inserter-medium) failed inspection-broken part-issue identified during service & repair activities of the evaluation set.There were no issues reported by the customer.Therefore, no additional information is available.This complaint involves one device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.A service and repair evaluation was performed.The customer reported the item had a broken part.The repair technician reported the inserter arm was broken.Worn out parts 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.A product investigation was performed.One inserter-medium (part number: pdl402, lot number: a7oa4; mfg.Date: 30mar2007) was received with the following complaint description: ¿service and repair department documented synthes evaluation equipment (inserter-medium) failed inspection-broken part-issue identified during service & repair activities of the evaluation set.There were no issues reported by the customer.Therefore, no additional information is available¿.The complaint condition is confirmed.A visual inspection, complaint history review, drawing review, and service and repair review (s&r) were performed as part of this investigation.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.Upon visual inspection of the device it can be seen that the superior bar (m) no longer attaches to the rest of the instrument.This is due to the ball plunger and pin becoming worn preventing the arm from staying attached to the rest of the instrument.The overall balance of the device was worn but consistent with 9+ years of regular use.Product drawings were found suitable to determine the intended device design, application and dimensional conformity.The medium inserter was found to have met the drawings specifications consistent with their date of manufacture.A device history review was performed for the returned instruments¿ lot numbers and in each instance no mrrs, ncrs or complaint-related issues were identified with the lots numbers which may have contributed to the complaint condition.No definitive root cause was able to be determined.However, the failure mode is typically associated with wear and tear over the devices 9+ year lifespan.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: INSERTER-MEDIUM
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6191847
• Report Number: 9680938-2016-10186
• Device Sequence Number: 359334
• Product Code: LXH
• UDI-Device Identifier: 10705034700557
• UDI-Public: (01)10705034700557(10)A7OA47
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 11/28/2016

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: PDL402
• Device Lot Number: A7OA47
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 01/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1