MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RATCHET WRENCH-11MM WIDTH ACROSS FLATS

Model Number	321.20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device returned.Occupation: synthes rep.A review of the device history record.Device history lot: part number: 321.20, synthes lot number: 5808592, supplier lot number: 011628, release to warehouse date: 02 jul 2008, expiration date: n/a, supplier: (b)(4).Device history batch null, device history review review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Investigation summary complaint summary: it was reported that on an unknown date, the sales consultant was given a broken item by sterile processing department (spd).There was no patient involvement.Flow: damage.Visual inspection: the ratchet wrench ¿ 11 mm width across flats (part # 321.20, lot # 5808592, mfg # 02-jul-2008) was received at us cq with no signs of breakage.The device looks a little worn.This is not consistent with the reported complaint condition.Therefore, the complaint is not confirmed.Dimensional inspection: dimensional analysis was not performed as there were no signs of breakage and the device is fully intact.Document/specification review: the following drawing(s) was reviewed; -11 mm ratchet wrench: 321_20 rev e and rev h.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.No new malfunctions were observed during the course of this investigation.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
It was reported that on an unknown date, the sales consultant was given a broken item by sterile processing department (spd).There was no patient involvement.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: RATCHET WRENCH-11MM WIDTH ACROSS FLATS
• Common Device Name: WRENCH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9765771
• Report Number: 2939274-2020-01094
• Device Sequence Number: 10941183
• Product Code: HXC
• UDI-Device Identifier: 10886982190444
• UDI-Public: (01)10886982190444
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2020

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: 321.20
• Device Catalogue Number: 321.20
• Device Lot Number: 5808592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 02/27/2020
• Patient Sequence Number: 1