MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC EXTRACTION SCREWDRIVER; SCREWDRIVERS

Catalog Number	352.311
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if there was patient involvement.No patient information was provided.It is unknown when device broke.Device is an instrument and is not implanted/explanted.Reporter email address is unknown.Part: 352.311; synthes lot: 5077319; supplier lot: n/a; release to warehouse date: september 20, 2005; expiration date: n/a; supplier: (b)(4).Review of the device history record (dhr) showed that there are potential issues during the manufacture of the product that would contribute to this complaint condition.Service & repair history: no service history review can be performed as part number 352.311 with lot number(s) 555563h05/5077319 is a lot/batch controlled item.The service history review is unconfirmed.Service & repair evaluation: the customer reported the tip of the screwdriver was broken.The repair technician reported the inner shaft tip was broken.Tip broken is the reason for repair.The cause of the issue is unknown.The following parts were replaced: inner shaft.The item was repaired per the inspection sheet, passed synthes final inspection on september 17, 2018 and will be returned to the customer upon completion of the service and repair process.Service record router completed through operation 30.Finalized service record will be archived.The evaluation was confirmed.Further review of the dhr found that a material review report (mrr) was related to an undersized tine to tine width at the tip of the device.The lot was inspected 100% for this feature and the non-conforming devices were scrapped.While the mrr would be relevant to a broken tip, because the lot was 100% inspected, this device does not exhibit the non-conforming condition.Therefore, the mmr did not cause this complaint condition.The device was deemed serviceable and returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.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
It was reported that on an unknown date, it was noted that the tip of an extraction screwdriver had broken off.It is unknown if there was procedure or patient involvement.This report is for an extraction screwdriver.This is report 1 of 1 for (b)(4).

• Brand Name: EXTRACTION SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7919954
• Report Number: 2939274-2018-53990
• Device Sequence Number: 16609086
• Product Code: HXX
• UDI-Device Identifier: 10705034770765
• UDI-Public: (01)10705034770765
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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: 352.311
• Device Lot Number: 5077319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1