MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC OPAL IMPLANT HOLDER PISTOL GRIP; MISC ORTHO SURGICAL INSTR

Model Number	03.803.002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.Device is an instrument and is not implanted/explanted.Patient code (b)(4) is used to capture no patient involvement.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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 during inspection of the set evaluation technician found that an opal implant holder was broken.There is no patient or procedure involved since the device was never used for surgery.This report is for one (1) opal implant holder pistol grip.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Device history records review was completed for part # 03.803.002, lot # 7609576.Supplier: (b)(4), release to warehouse date: mar 26, 2014.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The customer reported the instrument was broken.The repair technician reported the release assembly knob was stuck and marked up, and the shaft and handle were also marked up.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item was forwarded to customer quality.The evaluation was confirmed.The returned device (opal implant holder with pistol grip (03.803.002)) is noted in the opal spacer system technique guide where it is one of two options (the other being 03.803.001) for implant insertion.To attach an opal spacer to the holder, the knob at the proximal end must be rotated counter-clockwise to open the jaws, after which the jaws can be seated against the implant.Finally, the knob can be tightened (clockwise) to secure the implant.Insertion occurs with light impaction and, once the implant is in the correct position, the knob is rotated counter-clockwise to release the implant.Visual inspection at customer quality (cq) revealed that the inner shaft component is missing from the returned opal implant holder.Therefore, this complaint is confirmed, but for missing component rather than broken instrument.It is most likely that the device was disassembled for sterile processing and the inner shaft was misplaced.The release assembly knob is covered in nicks/ dings resembling witness marks from serrated tooth pliers.The outer shaft and the handle have the following written on them in black marker "broken".It is also observed that the part # and lot # etches are very faded/ barely legible.Review of the device history record(s) (dhr) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.Relevant drawings for the returned instrument were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition.A dimensional inspection is not possible as the inner shaft is missing and the knob has post manufacturing damage in the form of nicks/ dings resembling witness marks from serrated tooth pliers.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.

• Brand Name: OPAL IMPLANT HOLDER PISTOL GRIP
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7207396
• Report Number: 2939274-2018-50337
• Device Sequence Number: 1174219
• Product Code: LXH
• UDI-Device Identifier: 10705034722450
• UDI-Public: (01)10705034722450(10)7609576
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 12/28/2017

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 Model Number: 03.803.002
• Device Catalogue Number: 03.803.002
• Device Lot Number: 7609576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1