MAUDE Adverse Event Report: SYNTHES MONUMENT CROSS PINNED STRDRV SCRWDRVR SHAFT SELF-RETAINING T15/QC; SCREWDRIVERS

Catalog Number	03.614.018
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.(b)(6).A device history record review was performed on part # 03.614.018, lot # 5733711 (non-sterile) - cross pinned strdrv screwdrvr shaft self-retaining t15/qc.Quantity 29: manufacturing location: (b)(6), packaged by (b)(4), manufacturing date: 04-jun-2008.No (non-conformance reports) 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.Product development investigation was performed.The returned screwdriver was confirmed to have a cracked tip.In addition the tip was found to be broken with a missing fragment.The fracture pattern does not appear to be consistent with screw insertion/removal.The balance of the device is in good condition with no other issues noted.A visual inspection, drawing review and device history record (dhr) review were performed as part of this investigation.The complaint is confirmed.Replication of the complaint condition is not applicable as the device is already broken.Screw insertion is completed with a cross-pinned t15 screwdriver shaft (03.614.018).The screwdriver is one of three drivers (also 03.614.020 and 03.614.039) which can be utilized for the insertion of synapse polyaxial screws.The driver shaft is assembled with a holding sleeve (03.614.017) and a handle with quick coupling (324.107) to form an insertion assembly per relevant technique guide.The relevant drawings were reviewed during investigation.The design history was not found to impact the complaint condition.No definitive root cause was able to be determined.The broken and cracked tip was likely caused by excessive force or impact to the tip such as dropping the device.There were no issues during the manufacture of this product that would contribute to this complaint condition.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.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 on (b)(6) 2017, pre-operatively as the operating room nurse was setting up the sterile table for a spine cervical fusion procedure, it was noted that the end tip of the screwdriver was cracked.No additional time was added and another backup screwdriver was available in the operating room.No patient harm.During the manufacturer investigation process it was also identified that the tip of the screwdriver is broken and missing a fragment.This condition was re-evaluated and determined to be reportable on (b)(6) 2017.This is report 1 of 1 for (b)(4).

• Brand Name: CROSS PINNED STRDRV SCRWDRVR SHAFT SELF-RETAINING T15/QC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6363929
• Report Number: 1719045-2017-10148
• Device Sequence Number: 42336
• Product Code: HXX
• UDI-Device Identifier: 10705034714899
• UDI-Public: (01)10705034714899(10)5733711
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 01/03/2017

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: 03.614.018
• Device Lot Number: 5733711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2017
• Initial Report FDA Received Date: 02/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1