MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM; GAUGE,DEPTH

Model Number	SD319.002
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
Additional narrative: reporter is company representative without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 on an unknown date, one (1) trigger handle for cable cutter, one (1) inter-lock screwdriver, one (1) depth gauge, one (1) drive adaptor, three (3) reduction forceps and one (1) pointed reduction clamp were handed by the facility ortho director to the sales consultant as all the devices were broken.It is unknown if there were patient and surgical involvement.This complaint involves eight (8) devices.This is report 3 of 8 for pc- (b)(4).
Event or Problem Description
There was no patient involvement.
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.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.Investigation flow: damage.Visual inspection: the depth gauge for 2.0 mm and 2.4 mm screws -70 mm (p/n: sd319.002, lot #: h427975) was returned and received at us cq.Upon visual inspection, the needle component was observed to be broken and not returned.The protection sleeve was missing.No other issues were identified with the returned components of the device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review based on the date of manufacture the current and manufactured revision of drawings were reviewed.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion the complaint condition is confirmed for the depth gauge for 2.0 mm and 2.4 mm screws -70 mm (p/n: sd319.002, lot #: h427975).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 history lot part #: sd319.002, synthes lot number: h427975 , manufacturing site: synthes brandywine , release to warehouse date: feb 06, 2018.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM
• Common Device Name: GAUGE,DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10015188
• Report Number: 2939274-2020-02155
• Device Sequence Number: 3071122
• Product Code: HTJ
• UDI-Device Identifier: 10886982004925
• UDI-Public: (01)10886982004925
• Combination Product (Y/N): N
• 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,Followup,Followup,Followup
• Report Date (Section B): 04/15/2020

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: SD319.002
• Device Catalogue Number: SD319.002
• Device Lot Number: H427975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 05/21/2020; 06/01/2020; 06/08/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 05/21/2020; 06/02/2020; 06/10/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM; DRIVE ADAPTOR WITH QC FOR 5.0MM SCHANZ SCREWS; INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM; REDUCTION FORCEPS WITH POINTS NARROW-RATCHET 132MM; TRIGGER HANDLE F/CABLE CUTTER; UNK - FORCEPS