MAUDE Adverse Event Report: SYNTHES HAGENDORF 8.0MM/3.2MM DRILL SLEEVE 200MM; MISC ORTHO SURGICAL INSTR

Catalog Number	03.010.064
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product code use: fsm.Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.(b)(4).Device history records review was completed for part# 03.010.064, lot# 1683292.Manufacturing location: (b)(4), manufacturing date: may 16, 2007.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 investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) 2017, during a suprapatellar insertion of a nail, the drill bit contacted the nail through the aiming arm and insertion handle.Having missed the locking hole of the nail, the drill bit was backed out and the inner sleeve was removed.Additional fluoroscopy was used to locate the locking hole of the nail.With the inner sleeve removed, surgeon was then able to align the drill bit with the locking hole of the nail.Procedure was delayed approximately two minutes but was completed successfully with no harm to patient.Concomitant devices reported: 9 mm titanium cannulated tibial nail (part# 04.034.349s, lot# 9848027, quantity 1), protection sleeve with flats for suprapatellar (part# 03.010.442, lot# 7660447, quantity 1).This report is for one (1) 8.0 mm/3.2 mm drill sleeve 200 mm.This is report 4 of 4 for (b)(4).
Additional Manufacturer Narrative
Patient height reported as (b)(6).Patient id: (b)(6).A product investigation was completed : the 03.010.441 lot number 14-1990 aiming arm and 03.010.440 lot number 15-7233 insertion handle were returned and reported to have contributed to the 03.010.061 drill bit missing the locking hole.This complaint condition was likely caused by pressure from soft tissue or other intraoperative conditions; however, this complaint is not likely a result of any design or manufacturing related deficiency.A visual inspection, device history record review, complaint history review, design and clinical risk management review, and drawing review were performed as part of this investigation.This complaint is unconfirmed.The returned 03.010.442 lot number 7660447 12.0mm/8.0mm protection sleeve with flats was received without allegation or identifiable complaint condition.The 03.010.061 4.2mm three-fluted drill bit and 03.010.064 8.0mm/3.2mm drill sleeve used during this procedure were not returned.Per the technique guide, the 03.010.441 aiming arm, 03.010.440 insertion handle, and 03.010.061 4.2mm three-fluted drill bit are instruments routinely used in the suprapatellar instrumentation for titanium cannulated tibial nails system.The drill bit was reported to have missed the nail during surgery and that the returned insertion handle and aiming arm contributed to the misalignment.This condition is unconfirmed; the returned insertion handle and aiming arm assemble properly, and along with the returned protection sleeve, accurately target locking hole locations.The implanted nail and drill bit used during surgery were not returned to fully functionally test the construct.It is likely that pressure from soft tissue or other intraoperative conditions has led to this complaint condition.The aiming arm was manufactured in september 2014 and is over two years old.The insertion handle was manufactured in march 2016 and is a year old.The balance of each of the returned devices is in otherwise fairly good condition with only some superficial wear.The relevant drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does not agree with the complaint description.The complaint condition for this device cannot be replicated.Upon review of the device history record, no non-conformance reports germane to the complaint condition were generated during the production of this device.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: 8.0MM/3.2MM DRILL SLEEVE 200MM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6349589
• Report Number: 3003875359-2017-10079
• Device Sequence Number: 932871
• Product Code: LXH
• UDI-Device Identifier: 10886982067388
• UDI-Public: (01)10886982067388(10)1683292
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2017

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: 03.010.064
• Device Lot Number: 1683292
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2017
• Supplement Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART# 03.010.442, LOT# 7660447, QUANTITY 1; PART# 04.034.349S, LOT# 9848027, QUANTITY 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR
• Patient Weight: 88