MAUDE Adverse Event Report: SYNTHES TUTTLINGEN RIB EXPANSION PLIERS; PLIERS,SURGICAL

Catalog Number	388.471
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier and date of birth are not available for reporting.Patient weight in unknown, however patient is reported as very thin.Device is an instrument and is not implanted/explanted.Reporter phone number: (b)(6).A review of the device history records has been requested and is currently pending completion.The tip of the rib distractor pliers broke intraoperatively and generated fragments.The device tip was removed from the patient; however with difficulty.The 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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during a vertical expandable prosthetic titanium rib (veptr) ii expansion surgery performed on (b)(6) 2017, the tip of the rib expansion pliers broke after only two holes of distraction made.Fragment (device tip) was generated and it was retrieved, but with difficulty.Surgeon opened organic glue and were about to give up and let the fragment inside the distraction rack of veptr covered with glue.In a last attempt surgeon was able to suck the instrument tip.Surgery was prolonged for more than 20 minutes due to attempts made by surgeon to remove the piece of the instrument from the veptr extension hole.Reportedly there was no patient harm.Patient status reported as fine.Procedure was completed successfully this is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Device history records review was completed for part# 388.471, lot# a7qa46.Manufacturing location: (b)(4), manufacturing date: nov 20, 2007.No non conformance reports were generated during production.Review of the device history records showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the components and final product met inspection records, certification test values and acceptance criteria.All 32 parts of the lot were checked 100% for ctq features and for function at the final inspection on 19-nov-2007.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
Device was used for treatment, not diagnosis.The visual inspection of the returned rib distraction pliers has shown, that the pin on top of the instrument is completely broken off.There are also scratches and wear marks on the whole item visible.Additional it was also found, that the spring is bent and this is the reason that the instrument does not work as intended.Review of the device history records showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the components and final product met inspection records, certification test values and acceptance criteria.Unfortunately, we are not able to determine the exact cause which has lead to this occurrence.As this instrument is more than 9 years old, we suppose that the breakage were caused due to normal wear and tear over the years.The relevant dimension could not be measured as the pin of the rib distraction pliers is completely broken off.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RIB EXPANSION PLIERS
• Common Device Name: PLIERS,SURGICAL
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6527499
• Report Number: 9680938-2017-10072
• Device Sequence Number: 1345118
• Product Code: HTC
• UDI-Device Identifier: 07611819746671
• UDI-Public: (01)07611819746671(10)A7QA46
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 388.471
• Device Lot Number: A7QA46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 05/26/2017; 06/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 YR