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

Model Number	U44-642-20
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Customer quality investigation: the instrument(s) was not returned, and the investigation will be completed based on the supplied image(s) from the attachment(s) located in notes & attachments section of the product complaint.The image(s) was reviewed, and the complaint condition was confirmed as the image showed that the screw post locking spring broke from the driver.As the instrument(s) was not returned an as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation could not be performed as the lot number could not be determined from the provided image.There is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, that the pin holder was found to be broken.A lever was broken off, and it could not hold pins.This report involves one (1) screwdriver for pins.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Part number: u44-642-20.Lot number: at732.Manufacturing site: unknown.Release to warehouse date: unknown.Part/lot combination are unknown at synthes tuttlingen gmbh, no dhr review possible.Part number: u44-642-20.Lot number: a7fa44.Manufacturing site: (b)(4).Release to warehouse date: (b)(6) 1996.A review of the device history records is not possible, the dhr is no longer available due to the age of the instrument (over 23 years old).Customer quality investigation: the instrument(s) was not returned, and the investigation will be completed based on the supplied image(s) from the attachment(s) located in notes & attachments section of the product complaint.The image(s) was reviewed, and the complaint condition was confirmed as the image showed that the screw post locking spring broke from the driver.As the instrument(s) was not returned an as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation could not be performed as the lot number could not be determined from the provided image.There is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, 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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: a product investigation was conducted.Visual inspection: the screwdriver for pins (p/n: u44-642-20, lot number: a7fa44) was received at us cq.Visual inspection of the complaint device showed no damage to the device.The screw was unscrewed to check the post locking spring, which also had no damage.Investigation conclusion: this complaint is not confirmed as no damage was observed.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: SCREWDRIVER FOR PINS
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10074611
• Report Number: 2939274-2020-02457
• Device Sequence Number: 14292436
• Product Code: HXX
• UDI-Device Identifier: 10705034711102
• UDI-Public: (01)10705034711102
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2020

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: U44-642-20
• Device Catalogue Number: U44-642-20
• Device Lot Number: A7FA44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 06/26/2020; 07/31/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 07/14/2020; 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1